BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOND-III AUTOMATED SLIDE STAINER

    MDR report key: 18018060 · Received October 27, 2023

    Report

    Report Number
    8020030-2023-00036
    Event Type
    Injury
    Date Received
    October 27, 2023
    Date of Event
    September 1, 2022
    Report Date
    December 20, 2023
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD
    Product Code
    KPA
    UDI-DI
    09349458000004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO SECTION B6 TO INCLUDE ADDITIONAL INFORMATION PROVIDED BY THE COMPLAINANT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER EVALUATION OF THE SERVICE RECORD FOR THE INSTRUMENT SHOWED THAT A LEICA BIOSYSTEMS FIELD SERVICE ENGINEER WAS NOT DISPATCHED TO ASSESS THE OPERATION AND FUNCTION OF THE INSTRUMENT IN ASSOCIATION WITH THIS COMPLAINT. THE INFORMATION AVAILABLE DOES NOT IDENTIFY THE SPECIFIC STAINING RUN(S) WHERE "*ER FALSE POSITIVE SLIDES..." WAS REPORTED BY THE CUSTOMER. DETAILS OF THE AFFECTED TISSUE STAINING RUN(S) AND THE INSTRUMENT LOGS WERE NOT AVAILABLE TO THE MANUFACTURER. AS A RESULT, IT WAS NOT POSSIBLE TO ASSESS THE OPERATION AND FUNCTION OF THE INSTRUMENT. EVALUATION OF THE INFORMATION AVAILABLE BY THE GLOBAL TECHNICAL SUPPORT MANAGER - APPLICATIONS DETERMINED THE HEAT INDUCED EPITOPE RETRIEVAL (HEIR) PROTOCOL BEING USED BY THE COMPLAINANT IS NOT THE RECOMMENDED HEIR PROTOCOL IN THE LEICA ESTROGEN RECEPTOR CLONE 6F11 READY-TO-USE PRIMARY ANTIBODY FOR BOND¿ CATALOG NO: PA0151 (7 ML) / PA0009 (30 ML) INSTRUCTIONS FOR USE (IFU). THE IFU RECOMMENDS USING BOND EPITOPE RETRIEVAL SOLUTION 1 (ER1) FOR 20 MINUTES AND THE COMPLAINANT IS USING BOND EPITOPE RETRIEVAL SOLUTION 2 (ER2) FOR 30 MINUTES. THE GLOBAL TECHNICAL SUPPORT MANAGER - APPLICATIONS NOTED "ER2 30MINS IS A MUCH STRONGER HIER THAN THE RECOMMENDED. THIS MAY BE A CAUSE FOR THE STAINING ARTEFACT SEEN." THE GLOBAL TECHNICAL SUPPORT MANAGER - APPLICATIONS FURTHER NOTED "...THERE IS NOT AN ISSUE WITH BOND INSTRUMENTS, THE CUSTOMER IS USING THE CORRECT REAGENTS, BOND LEICA SLIDES AND OTHER CONSUMABLES. OTHER THAN THE ISSUE WITH THE PA0009 ER AB THERE IS NO ISSUE WITH OTHER ANTIBODIES REPORTED BY THE CUSTOMER." THE ROOT CAUSE FOR THE "ER FALSE POSITIVE SLIDES..." REPORTED BY THE COMPLAINANT WAS DETERMINED BY THE GLOBAL TECHNICAL SUPPORT MANAGER - APPLICATIONS TO BE OFF-LABEL USE OF THE BOND EPITOPE RETRIEVAL SOLUTION. DETAILS OF THE AFFECTED TISSUE STAINING RUN(S) AND THE INSTRUMENT LOGS WERE NOT AVAILABLE TO THE MANUFACTURER. AS A RESULT, IT WAS NOT POSSIBLE TO ASSESS THE OPERATION AND FUNCTION OF THE INSTRUMENT. HOWEVER, BASED ON THE INFORMATION AVAILABLE, THE GLOBAL TECHNICAL SUPPORT MANAGER - APPLICATIONS DETERMINED THE INSTRUMENT FUNCTIONED AS DESIGNED IN THE CIRCUMSTANCES REPORTED BY THE COMPLAINANT.

    Description of Event or Problem · 0

    ON (B)(6) 2023, LEICA BIOSYSTEMS MELBOURNE RECEIVED THE FOLLOWING INFORMATION FROM THE LOCAL LEICA SENIOR APPLICATION CONSULTANT: "1 PATIENT: PROBABLE HARM, DID NOT HAVE NEOADJ [SIC] CHEMO, STOPPED HORMONAL THERAPY, 5 PATIENTS: DOUBT ABOUT CLINICAL CONSEQUENCE (PARTIAL TTT RESPONSES TO NEOADJ [SIC] CHEMO OR NO NEOADJ [SIC] CHEMO), 2 PATIENTS: HORMONAL THERAPY DISCONTINUATION". AN IDENTIFIER, AGE OR DATE OF BIRTH AND GENDER FOR THE EIGHT (8) PATIENT CASES FOR WHICH THERE IS "POSSIBLE HARM." HAS NOT BEEN PROVIDED TO LEICA BIOSYSTEMS.

    Description of Event or Problem · 0

    ON (B)(6) 2023, LEICA BIOSYSTEMS BECAME AWARE OF THE FOLLOWING COMPLAINT: "*ER FALSE POSITIVE SLIDES FROM (B)(6) 2022 TO (B)(6) 2023, AROUND [SIC] 40 FALSE POSITIVE *ER SLIDES GOT NOTICED BY CUSTOMER...THEY STAINED AGAIN PREVIOUS ER CASES ON BOND-III AND [INSTRUMENT] AND GOT VERY DIFFERENT RESULTS. AROUND [SIC] 63% OF RE-TESTED SLIDES WERE FALSE-POSITIVE WITH *ER. SINCE (B)(6) 2023, NO MORE STAINING ISSUE, FOR UNKNOWN REASON." THE LEICA SENIOR APPLICATION CONSULTANT (FAS) DOCUMENTED THE "*ER FALSE POSITIVE" REPORTED BY THE COMPLAINANT AFFECTED 39 PATIENT SLIDES IN TOTAL, WHICH WERE STAINED USING FIVE (5) BOND-III INSTRUMENTS AT THE [CUSTOMER SITE]. ON (B)(6) 2023, THE FAS DOCUMENTED PATIENTS HAD RECEIVED TREATMENT BASED ON THE INITIAL RESULTS RECEIVED AND THAT "THE LABORATORY IS CURRENTLY SENDING CORRECTED DIAGNOSES TO DOCTORS." ON (B)(6) 2023, THE FAS PROVIDED INFORMATION THAT ALTHOUGH THE CUSTOMER FIRST IDENTIFIED THE ISSUE INTERNALLY IN (B)(6), THEY DID NOT REPORT THE ISSUE UNTIL (B)(6) 2023 AS "IT TOOK SOME TIME TO THE CUSTOMER TO REALIZE AND INVESTIGATE (THEY ARE STILL ON IT) AND TO IDENTIFY THE STAINING PROBLEM." ON (B)(6) 2023, THE FAS PROVIDED FURTHER INFORMATION REGARDING THE CIRCUMSTANCES INVOLVED IN THIS COMPLAINT. THE FAS DOCUMENTED: "REPEATABILITY ISSUES WITH LEICA RTU ESTROGEN RECEPTOR (*ER PA0009) ON ALL 3 CUSTOMERS SITE [CUSTOMER SITES] WITH FALSE POSITIVE (ER2) OR FALSE NEGATIVE (ER1)." THE FAS DOCUMENTED THE TYPE(S) OF THE AFFECTED PATIENT SAMPLES WERE "BREAST BIOPSIES OR BIGGER BREAST SAMPLES", THE TISSUE STAINING ARTEFACT WAS DESCRIBED AS "ARROUND [SIC] 50 FALSE POSITIVE SLIDES NOTICED" AND IT WAS NOTED THE STAINING ARTEFACT AFFECTED "...3 LABS FROM THE SAME GROUP (WITH 3 DIFFERENT PRE-ANALYTICS). FALSE POSITIVE ISSUES FROM (B)(6) 2022 TO (B)(6) 2023 (WITH NUCLEAR BACKGROUND), IT STOPPED IN (B)(6) FOR UNEXPLAINED REASON !... TODAY, RANDOM FALSE NEGATIVE ISSUES WITH ER1 30'." ON (B)(6) 2023, LEICA BIOSYSTEMS MELBOURNE RECEIVED THE FOLLOWING INFORMATION FROM THE LOCAL LEICA SENIOR APPLICATION CONSULTANT: "...2 PATIENTS RECEIVED INAPPROPRIATE TREATMENT (POSSIBLY SURGERY)." ON (B)(6) 2023, LEICA BIOSYSTEMS MELBOURNE RECEIVED CONFIRMATION FROM THE LOCAL LEICA SENIOR APPLICATION CONSULTANT THAT "...AROUND 50 CASES..." AT THIS SITE RESULTED IN FALSE POSITIVE SLIDES AND "...2 PATIENTS RECEIVED AN INAPPROPRIATE TREATMENT BECAUSE OF A MISDIAGNOSIS." AN IDENTIFIER, AGE OR DATE OF BIRTH AND GENDER FOR THE TWO (2) PATIENT CASES WHICH "...RECEIVED AN INAPPROPRIATE TREATMENT BECAUSE OF A MISDIAGNOSIS." HAS NOT BEEN PROVIDED TO LEICA BIOSYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1701038 BOND-III AUTOMATED SLIDE STAINER AUTOMATED SLIDE STAINER KPA LEICA BIOSYSTEMS MELBOURNE PTY. LTD BOND-III 09349458000004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other